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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01015755
Other study ID # 1R01NR011825-01
Secondary ID
Status Completed
Phase Phase 0
First received November 17, 2009
Last updated March 7, 2013
Start date January 2010
Est. completion date July 2012

Study information

Verified date March 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Patients in Intensive Care Units are often extremely thirsty due to their medicines, illness, treatments or medicines that they receive. This study will test whether patients who receive a easy to implement intervention for thirst will have greater relief from thirst than a group of patients who do not receive the intervention. The study will also identify the most important factors that make ICU patients thirsty so that future research studies can test how to relieve those factors and/or make interventions for thirst more readily available.


Description:

This study will test the efficacy of an innovative, inexpensive, resource-efficient treatment for thirst -- one of the most pervasive, intense, unrecognized, and under-treated symptoms suffered by critically ill patients in Intensive Care Units (ICUs). The first aim of this single-blinded, randomized clinical trial is to test a non-pharmacologic intervention for thirst in ICU patients. The intervention is a combination therapy treatment (CTT) for thirst that includes the use of sterile water mouth sprays, sterile water swabs, and menthol-based lip and tongue moisturizer. The second aim of the study is to examine demographic, environmental, and health and illness factors that increase an ICU patient's risk profile for thirst. Aim #1 hypotheses: (1) Thirst intensity and distress will decrease significantly in ICU patients who receive a CTT for thirst compared to those who receive research team observation. (2) Subjective (e.g., dry mouth) and objective (e.g., cracked lips) thirst-related characteristics will decrease significantly in ICU patients who receive a CCT for thirst compared to those who receive research team observation. Aim #2 hypotheses: (1) A significant association will be found between presence of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids. (2) A significant association will be found between the intensity of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids.

The sample will be 245 ICU patients in one Experimental and two Control groups. Those with thirst will be randomized to either the Experimental or the Control 1 group. The Experimental group will receive the CTT; the Control 1 group will receive research team observation. The Control 2 group patients who reported no thirst will be compared to the Control 1 group on characteristics associated with the presence and intensity of thirst.

Multilevel linear regression models will be employed to test the difference in the linear change trajectories between the treatment and control groups. Multiple logistic regression analysis and multiple linear regression analysis will be used to determine association of risk factors with the presence and intensity of thirst, respectively.

Results will contribute empirical data needed to stimulate a far overdue nursing practice change for the treatment of thirst in ICUs. Results will also identify a risk profile for thirst that will be an important target for future research of thirst in ICU patients.


Recruitment information / eligibility

Status Completed
Enrollment 353
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- must be able to self-report thirst intensity or distress

Exclusion Criteria:

- unable to self-report thirst

- comatose

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
combined therapy treatment
mouth care

Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thirst intensity after thirst intervention No
Secondary Thirst distress after thirst intervention No
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